Pelvic health implants and methods

ABSTRACT

Surgical articles, implants and components suitable for female pelvic health procedures are described.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation-in-part of U.S. patentapplication Ser. No. 09/917,443, filed Jul. 27, 2001 and of U.S. patentapplication Ser. No. 10/280,341, filed Oct. 25, 2002, and claimspriority to both utility applications and to U.S. ProvisionalApplication Serial No. 60/380,591, filed May 15, 2002; and U.S.Provisional Application Serial No. 60/456,750, filed Mar. 21, 2003. Theentire contents of all of those patent applications are hereinincorporated by reference.

BACKGROUND

[0002] Pelvic floor disorders include cystocele, rectocele, enterocele,and prolapse such as anal, uterine and vaginal vault prolapse. Acystocele is a hernia of the bladder, usually into the vagina andintroitus. These disorders typically result from weakness or damage tonormal pelvic support systems.

[0003] In its severest forms, vaginal vault prolapse can result in thedistension of the vaginal apex outside of the vagina. An enterocele is avaginal hernia in which the peritoneal sac containing a portion of thesmall bowel extends into the rectovaginal space. Vaginal vault prolapseand enterocele represent challenging forms of pelvic disorders forsurgeons. These procedures often involve lengthy surgical proceduretimes.

[0004] Synthetic implants have been used to address pelvic organprolapse. See Julian, The Efficacy of Marlex Mesh in the Repair ofSevere, Recurrent Vaginal Prolapse of the Anterior Midvaginal Wall, Am.J. Obstet Gynec, Vol. 175, No. 6 (1996) (Pps 1472-1475). Ahammock-shaped polypropylene mesh is described in Nicita, A NewOperation For Genitourinary Prolapse, J. of Urology, Vol. 160, 741-745(September 1998). The mesh is taut and anchored transversely between thetwo arcus tendineus of the endopelvic fascia and in the anteroposteriordirection between the bladder and uterine necks. The width of the meshis equal to the anteroposterior dimension of cystocele.

[0005] Migliari et al used a 5×5 cm mixed (60% polyglactin 910 and 40%polyester) fiber mesh to treat cystocele. See Migliari et al., TreatmentResults Using a Mixed Fiber Mesh in Patients With Grade IV Cystocele, J.of Urology, Vol. 161, 1255-1258 (April 1998). Meshes provided in squareor rectangular configurations must be trimmed to form a complex shape.This can add to the length of the surgical procedure.

[0006] Vaginal vault prolapse is often associated with a rectoecle,cystocele or enterocele. It is known to repair vaginal vault prolapse bysuturing to the utero sacral ligaments, the sacrospinous ligaments orthe levator muscles. It is also known to repair prolapse by attachingthe vaginal vault through mesh or fascia to the sacrum. Many patientssuffering from vaginal vault prolapse also require a surgical procedureto correct stress urinary incontinence that is either symptomatic orlatent.

[0007] Italian Patent No. 01299162 describes a first prosthesis meshhaving a first section designed to be applied to a bladder cavity and asecond section designed to be applied to the bladder below the bladderneck. The first prosthesis includes a pair of flaps that are designed tobe applied to the urethropelvic ligament and are separated from thefirst section by slits. The first prosthesis may be used to treaturogenital prolapse. A second prosthesis for treating rectocele isdisclosed. The second prosthesis is separate and distinct from the firstprosthesis.

[0008] A sacral colpopexy is a procedure for providing vaginal vaultsuspension. It may be performed through an abdominal incision orlaparoscopically. Complications include mesh infection, mesh erosion,bowel obstruction, and bleeding from the presacral venous complex.Typically, this procedure is accompanied by an abdominal enterocelerepair and cul-de-sac obliteration.

[0009] A sacral colpopexy entails suspension of the vaginal cuff to thesacrum with fascia or synthetic mesh. The synthetic mesh is typicallycarefully customized or assembled into a special shape by the surgeon. Asurgeon manually cuts a sheet of the mesh and stitches elements of themesh to form the special shape. The literature reports surgeons suturingmesh material into various T-shaped articles. See Paraiso et al,Laparoscopic Surgery for Enterocele, Vaginal Apex Prolapse andRectocele, Int Urogynecol J (1999), 10:223-229.

[0010] A sacral colpopexy can be a tedious, challenging surgicalprocedure. Average procedure lengths of 247 minutes were reported inWinters et al., Abdominal Sacral Colpopexy and Abdominal EnteroceleRepair in the Management of Vaginal Vault Prolapse, Urology 56 (Suppl6A) (2000): 55-63. At least some of this time can be attributed to thetime required for the surgeon to construct an implant. Non-laparoscopicsurgical procedure lengths can be shorter, but such procedures involve alarge abdominal incision with the attendant risk of morbidity andinfection. Many surgeons seek to avoid sacral colpopexy procedures for avariety of different reasons, including the amount of surgical activityin proximity to sensitive areas such as the sacrum.

[0011] It is reported that 72% of patients with vault prolapse had acombination of other pelvic floor defects. See Richter K: MassiveEversion of the Vagina: Pathogenesis, Diagnosis and Therapy of the TrueProlapse of the Vaginal Stump, Clin. Obstet Gynecol 25:897-912 (1982).If surgical correction of cystocele, rectocele or stress incontinence isperformed in the presence of untreated vaginal vault prolapse, it isspeculated that an early recurrence of prolapse is extremely likely.When it is considered that it is often necessary to correct multiplepelvic floor disorders simultaneously, the time factor for surgeons isparticularly challenging. See, Diana et al., Treatment of Vaginal VaultProlapse with Abdominal Sacral Colpopexy Using Prolene Mesh, AmericanJournal of Surgery, Vol. 179, (February 2000), Pps. 126-128.

[0012] A sacrospinous ligament fixation surgical procedure is aprocedure that involves attaching the vault of the vagina to thesacrospinous ligament. See Guner et al., Transvaginal SacrospinousColpopexy For Marked Uterovaginal and Vault Prolapse, Inter. J. ofGynec. & Obstetrics, 74 (2001) Pps. 165-170. Sacrospinous ligamentfixation procedures are believed to require specialized, technicalskills. There are additional drawbacks. For example, the procedure tendsto place the vagina in an artificial anatomical position (as opposed toa natural position), especially if the procedure is performedunilaterally which tends to pull the vagina to one side.

[0013] U.S. Pat. No. 5,840,011 discloses an implant for suspension ofthe urinary bladder to treat incontinence. The implant includes foursecurement appendages. The patent states that two securement appendagesare drawn retrosymphyseally between the bladder and vagina and arepositioned exactly. The other two securement appendages are fixed to theligamentum pubicum superior behind the two pubic rami.

[0014] U.S. Pat. No. 6,306,079 discloses a mesh pubovaginal slingcomprising two mesh pieces, including a first mesh portion ofpolypropylene and a second mesh portion comprising an absorbablematerial. One piece is inserted at the endopelvic fascia and the otherat the suprapubic region.

[0015] PCT Publication No. WO 00/64370 (Gaston) describes a device fortreating a prolapse by vaginal suspension. The device comprises anelongate, flexible, pierced material, a suture connected to the materialand a suture needle joined to the suture. The device is long enough toenable posterior suspension of the vagina at the promontory (i.e. thefront upper part of the sacrum). The other end of the device includes adistal portion having a width such that it can cover at least a largepart of the posterior part of the vagina, a rounded cut-out withdimensions that enable it to be engaged around the base of the vagina onat least a large part of the lower half of the wall of the vagina. Thesuture is connected to the article so that it is offset sidewise inrelation to the cut-out.

[0016] PCT Publication No. WO 00/27304 (ORY et al.) discloses asuspension device for treating prolapse and urinary incontinence. Thedevice comprises at least one filiform suspension cord with limitedelasticity and at least two anchoring parts linked to the ends of thecord.

[0017] U.S. Pat. No. 5,112,344 and PCT Publication No. PCT/US02/32284disclose surgical devices for female pelvic health procedures. The IVSTunneller device is available from U.S. Surgical of Norwalk, Conn. TheIVS device comprises a fixed delta wing handle, a hollow metal tube anda stylet that is placeable within the tube. The stylet has a roundedplastic tip on one end and an eyelet at the other end. The device may beused to implant a polypropylene tape for infracoccygeal sacropexy andother surgical procedures. See Farnsworth, Posterior IntravaginalSlingplasty (Infracoccygeal Sacropexy) For Severe PosthysterectotiyVaginal Vault Prolapse—A Preliminary Report on Safety and Efficacy, Int.Urogynecol. J. (2002) 13:4-8; Petros, Vault Prolapse II. Restoration ofDynamic Vaginal Supports by Infracoccygeal Sacropexy, an Axial Day-CaseVaginal Procedure, Int Urogynecol J (2001) 12:296-303; and Petros, TheIntravaginal Slingplasty Operation, a Minimally Invasive Technique forCure of Urinary Incontinence in the Female, Aust. N Z J Obstet Gynaecol,(1996); 36: 4:453.

[0018] A single, rigid, hollow metal tube is associated with the IVSTunneller device. This single tube passes through two separate regionsof the patient's body with the attendant risk of cross contamination.The outer diameter of the tube is also relatively large (about 0.25inches) with the attendant risk of tissue damage due to a large diameterneedle.

[0019] The polypropylene tape supplied with the IVS Tunneller is a thin,rectangular shape, believed to be approximately 8 mm×350 mm. The thin,rectangular tape supplied with the IVS Tunneller is not believed to beoptimally sized and shaped to afford concomitant procedures such asenterocoele, cystocele and/or rectocoele repairs encountered in manycases. The tape is also inextensible. Under a longitudinal force, theimplant is highly resistant to elongation. It is believed thatinextensible polypropylene tapes may be apt to exhibit a greaterassociation with erosion and failure.

SUMMARY OF THE INVENTION

[0020] In one aspect, the present invention comprises a novel implantsuitable for addressing one or more disorders including incontinence,cystocoele, rectocoele, enterocoele and prolapse (e.g. uterine and/orvaginal vault). Preferably, the implant is conformable to irregularsurfaces and to accommodate different anatomy shapes and sizes. In oneembodiment, the implant is preassembled or pre-cut in a predeterminedshape to simultaneously address incontinence and cystocele repairs in atension-free manner and to afford efficient use of the surgeon's time.In another embodiment, the implant includes features affordingconvenient assembly of a composite implant so that the implant may becustomized according to the surgeon's preference or the needs of aparticular surgical procedure. In yet another embodiment, the implantincludes indicia for convenient trimming of a bulk implant to addressthe particular needs of a procedure.

[0021] In one aspect, the present invention comprises a mesh having amajor portion that is sized and shaped to afford repair of a cystocele.The implant is preferably secured in the body without lifting thepatient's bladder and without placing tension on the bladder. Theimplant includes a urethral support portion capable of being placedunderneath the patient's urethra; and first and second sling appendagesto be placed on different sides of the urethra.

[0022] The sling appendages may be sized and shaped to be secured in thepatient's abdominal rectus fascia. Alternatively, the sling appendagesmay be sized and shaped to extend from a region near the patient'surethra to at least the patient's obturator foramen.

[0023] The portion of the implant generally opposite the slingappendages may take a variety of different forms. In one embodiment, theportion of the implant opposite the sling appendages may be designed tomerely address a cystocele or both a cystocele and a rectocele. Inanother embodiment, it may be sufficiently long and appropriately shapedto extend to incisions on opposite sides of the patient's anus. Inanother embodiment, it may have a length sufficient to afford anchoringin the region of the patient's sacrum, or the sacrospinous ligaments, orthe uterosacral ligaments, or the levator ani tissues.

[0024] For certain configurations of implant and for certain uses of theimplant (e.g. posterior vaginal vault repair), the present inventioncomprises constructing the implant from a longitudinally extendablematerial. This affords an implant that is relatively longitudinallyextendable, unlike prior art implants used in posterior vault repairprocedures. In this aspect, the present invention comprises a syntheticmesh material having a portion adapted to be secured in the patient'svaginal region, a first posterior securement appendage that is sized,shaped and configured to extend from the patient's vaginal region to afirst incision in the patient's buttocks that is lateral to thepatient's anus; and a second posterior securement appendage that extendsto the opposite side of the patient's anus.

[0025] The bulk material from which the mesh is supplied has at least aLongitudinal Elongation Factor (LEF) of at least 0.06 under a ½ poundload. More preferably, the bulk material from which the mesh is suppliedhas at least a Longitudinal Elongation Factor (LEF) of more than about0.08 under a ½ pound load, even more preferably it is more than about0.15. Preferably, bulk material from which the mesh is supplied has aLongitudinal Elongation Factor (LEF) of more than about 0.08 under a 1pound load, more preferably it is more than about 0.1 under a 1 poundload, and even more preferably it is more than about 0.2 under a 1 poundload.

[0026] Preferably, the synthetic mesh materials used comprise bulkknitted polypropylene monofilaments, but a variety of differentmaterials are contemplated. The implant is preferably knitted to besupple, conformable and to afford tissue ingrowth. In one embodiment theimplant is a composite constructed of two different implantablematerials.

[0027] In another aspect, the present invention comprises a syntheticmesh material having a portion adapted to be secured in the patient'svaginal region, a first posterior securement appendage that is sized,shaped and configured to extend from the patient's vaginal region towarda first incision in the patient's buttocks that is lateral to thepatient's anus; a second posterior securement appendage placeable on aside of the patient's anus different than that of the first posteriorsecurement appendage. The implant includes a first flexible insertionsheath associated with at least a portion of the first posteriorsecurement appendage, and a second flexible insertion sheath associatedwith at least a portion of the second posterior securement appendage.

[0028] Preferably, the first and second posterior securement appendageshave distal end regions adapted to be secured in the patient'sischioanal or ischiorectal fossa. Alternatively, the first and secondposterior securement appendages have distal end regions adapted to besecured in the patient's sacrospinous ligaments or the uterosacralligaments or levator ani tissue.

[0029] In another aspect, the present invention comprises an implantassembly suitable for placement through incisions in the patient'sbuttocks on opposite sides of the anus. The novel implant assembliesinclude one or more of: i) connectors for associating the implantassembly with the distal end of an insertion needle, ii) dilators fordilating tissue, iii) insertion sheaths, iv) tensioning sutures, and v)an elongatable, conformable mesh.

[0030] In another aspect, the present invention comprises a surgicalimplant for addressing incontinence and cystocele disorders comprising asynthetic mesh material having a cystocele repair portion adapted to besecured in the patient's vaginal region, a first posterior securementappendage that is sized, shaped and configured to extend from thepatient's vaginal region toward a first incision in the patient'sbuttocks; and a second posterior securement appendage opposite thefirst. The implant includes a urethral support portion capable of beingplaced underneath the patient's urethra; a first sling appendage forsecurement on a first side of the patient's urethra; and a second slingappendage for securement on a side of the patient's urethra generallyopposite the first.

[0031] In another aspect, the present invention comprises a syntheticmesh material having a portion adapted to be secured in the patient'svaginal region. The mesh has a first posterior securement appendage thatis sized, shaped and configured to extend from the patient's vaginalregion toward a first incision in the patient's buttocks; and a secondposterior securement appendage opposite the first. In this embodiment,the first and second posterior securement appendages include a connectorfor associating the first and second posterior securement appendageswith a distal end of an insertion needle.

[0032] The present invention includes surgical kits comprising first andsecond insertion needles having distal ends. Preferably, the first andsecond insertion needles are configured so that their distal ends may beinitially inserted through an incision in the patient's buttocks andthen passed through tissue, emerging through a vaginal incision. Thekits also include an implant comprising a synthetic mesh material havinga portion adapted to be secured in the patient's vaginal region torepair, for example, a vaginal vault prolapse. The mesh has a firstposterior securement appendage that is sized, shaped and configured toextend from the patient's vaginal region toward a first incision in thepatient's buttocks; and a second posterior securement appendagegenerally opposite the first. Preferably, this embodiment includes firstand second flexible insertion sheaths associated with at least a portionof the first and second posterior securement appendages.

[0033] In another embodiment, the present invention comprises asynthetic mesh having a major portion, and at least four projectionsextending from the major portion. One of the projections is adapted tobe placed on a first side of the patient's urethra and extend from thepatient's urethral region to the patient abdominal rectus fascia, andanother of the projections is adapted to be placed on a side of thepatient's urethra generally opposite the first side. This embodimentpreferably includes at least one connector (preferably four) forassociating the implant with at least one (preferable four) insertionneedle.

[0034] In another aspect, the present invention comprises a modularassembly for affording construction of a surgical implant for addressingone or more pelvic floor disorders. The assembly comprises an anteriorelement for affording a sling-like implant; a posterior element forsecurement in a posterior region of the patient's body; and a cystocelerepair portion for affording repair of a cystocele, wherein thecystocele repair portion may be associated with either the anteriorelement or the posterior element or both elements. Preferably theassembly includes a means for facilitating association between elementsof the assembly. Also preferably, the cystocele repair portion includesindicia to facilitate trimming to adjust the implant to different sizes.A rectocele repair portion may also be provided.

[0035] In yet another aspect, the present invention comprises novelsurgical procedures that utilize the novel implants and implantassemblies.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Other features and advantages of the present invention will beseen as the following description of particular embodiments progressesin conjunction with the drawings, in which:

[0037]FIG. 1 is a top view of an assembly for creating a compositeimplant, showing three different options for a portion of the implant;

[0038]FIG. 2 is a perspective view of a portion of a component of FIG.1, showing the component in an open position;

[0039]FIG. 3 is top view of another embodiment of implant according toan aspect of the present invention;

[0040]FIG. 4 is a top view of another embodiment of implant;

[0041]FIG. 5 is a top view of another embodiment of implant;

[0042]FIG. 6 is an exploded perspective view of a surgical kit accordingto another aspect of the present invention;

[0043]FIG. 7 is a schematic view illustrating a cystocele;

[0044]FIGS. 8 through 13 sequentially illustrate an embodiment of asurgical procedure according to an aspect of the present invention,wherein:

[0045]FIG. 8 is a schematic view showing the locations of incisionsproximate ischioanal fossa or ischiorectal fossa, and two separateneedles for passage through an incision;

[0046]FIG. 9 schematically illustrates a surgeon passing a surgicalneedle from the incision proximate the patient's ischioanal fossa orischiorectal fossa to a vaginal incision;

[0047]FIG. 10 is a schematic side view showing the distal end of theneedle of FIG. 9 after it emerges from an incision in the region of thevaginal apex, and a dilator connector of an implant;

[0048]FIG. 11 is a schematic illustration of the surgeon guiding thedistal end of the needle of FIG. 10;

[0049]FIG. 12 is a perspective view of an implant after it has beenplaced in a patient and showing portions of the implant emerging fromthe incisions proximate the patients ischioanal fossa or ischiorectalfossa;

[0050]FIG. 13 is a schematic side view showing one embodiment of implantaccording to the present invention after it has been inserted in thepatient;

[0051]FIG. 14 is a top view of another embodiment of implant;

[0052]FIG. 15 is a top view of another embodiment of implant;

[0053]FIG. 16 is a top view of another embodiment of implant similar toFIG. 15 with an additional element shown in phantom lines;

[0054]FIG. 17 is a bottom view of another embodiment of implantaccording to the present invention;

[0055]FIG. 18 is an enlarged perspective view of a portion of theimplant of FIG. 17;

[0056]FIG. 19 is a schematic view of the implant of FIG. 17 implanted invitro;

[0057]FIG. 20 is a top view of another embodiment of implant accordingto the present invention;

[0058]FIG. 21 is a schematic view of the initial length of a piece ofbulk material, which view helps describe a test for determining amaterial's Longitudinal Elongation Factor;

[0059]FIG. 22 is a schematic side view of a force being applied to thematerial of FIG. 21, and showing an elongation distance;

[0060]FIG. 23 is another embodiment of implant according to the presentinvention, which implant includes indicia to afford convenient trimmingto a predetermined shape;

[0061]FIG. 24 is a side view of a portion of the implant of FIG. 23,taken approximately at lines 24-24 in FIG. 23;

[0062]FIG. 25 is a perspective view of a novel assembly for addressingvaginal vault prolapse that includes a longitudinally extendable sling;

[0063]FIG. 26 is a top view of another embodiment of the presentinvention; and

[0064]FIG. 27 is a top view of an assembly for creating a compositeimplant, showing an anterior portion, a major portion and a posteriorportion, and showing three different options for a major portion of theimplant.

DETAILED DESCRIPTION

[0065] The following description is meant to be illustrative only andnot limiting. Other embodiments of this invention will be apparent tothose of ordinary skill in the art in view of this description.

[0066] The present invention is directed to surgical instruments,assemblies and implantable articles for treating one or more pelvicfloor disorders including cystocele, rectocele, enterocele, incontinenceand uterine, anal or vaginal vault prolapse.

[0067] Referring to FIGS. 1 and 2, there is shown a modular assembly 10for creating a customized surgical implant for treating a femalepatient's pelvic health disorder. The assembly includes a mesh. The meshmay be assembled from diverse materials. For example, the mesh may beassembled from a synthetic material 12 and a non-synthetic material(e.g. one of 32, 34 or 36).

[0068] The assembly 10 has a major or cystocele repair portion (e.g. 32,34 or 36) that is sized and shaped to afford repair of a cystocelewithout lifting the patient's bladder and without placing undue tensionon the bladder or vaginal wall. The major portions may have apredetermined size and shape. For example one major portion may be sizedand shaped to correct a midline defect. Another major portion may besized and shaped to address a lateral defect. Yet another major portionmay be designed to address large defects, while another may be designedto address a small defect.

[0069] Preferably, the implant may be implanted in a tension free mannerand affords tissue in-growth for vaginal wall support. Alternatively themajor portion may have a portion that is sized and shaped to address arectocele. The rectocele portion may be provided as an integral piece orit may be attachable.

[0070] The implant also includes a urethral support portion 12 capableof being placed underneath the patient's urethra, a first slingappendage 14 for securement on a first side of the patient's urethra;and a second sling appendage 17 for securement on a side of thepatient's urethra generally opposite the first side. The urethralsupport portion 12 is preferably placed adjacent a mid region of theurethra in a tension free manner. Other placements are also contemplatedherein such as at the bladder neck.

[0071] In one embodiment, the first sling appendage 14 is sized, shapedand configured to extend from a region near the patient's urethra to anincision in the patient's abdominal rectus fascia, on a first side ofthe patient's urethra, and the second sling appendage 17 is sized,shaped and configured to extend from a region near the patient's urethrato an incision in the patient's abdominal rectus fascia, on a side ofthe patient's urethra generally opposite the first side. In thisembodiment, the width of the sling appendages 14 and 17 is preferablybetween 0.5 and 2 cm, more preferably between about 0.7 and 1.2 cm, morepreferably about 1.1 cm. The distance between the ends of the slingappendages 14 and 17 (the transverse length) is preferably between about40 and 60 cm, more preferably between 45 and 55 cm and even morepreferably about 50 cm. As shown in FIG. 1, the implant 10 includesoptional insertion sheaths 11, described in greater detail below.

[0072] In another embodiment, the first sling appendage 14 is sized,shaped and configured to extend from a region near the patient's urethrato the patient's obturator foramen, on a first side of the patient'surethra, and the second sling appendage 17 is sized, shaped andconfigured to extend from a region near the patient's urethra to thepatient's other obturator foramen, on a side of the patient's urethragenerally opposite the first side. In this embodiment, the width of thesling appendages 14 and 17 is preferably between 0.5 and 2 cm, morepreferably between about 0.7 and 1.2 cm, more preferably about 1.1 cm.The distance between the ends of the sling appendages 14 and 17 (thetransverse length) is preferably between about 30 and 40 cm, and evenmore preferably about 35 cm. Surgical tools for inserting a sling in theregion of the patient's obturator foramen are disclosed in U.S. patentapplication Ser. No. 10/306,179, filed Nov. 27, 2002.

[0073] In a preferred embodiment, one material comprises a syntheticmaterial (e.g. 12) and another material comprises a biomaterial (e.g. 32in FIG. 1) or non-synthetic material. In another embodiment, onematerial comprises an absorbable material and the other materialcomprises a non-absorbable or permanent material. In another embodiment,one portion may be resorbable or absorbable, another portion may benon-absorbable and another portion may be constructed of a differentmaterial. A naturally occurring biomaterial may be used or a tissueengineered material may be used.

[0074] As used in this application, when it is said that one implantmaterial is different than another implant material, it is meant thatthe materials substantially differ in a feature that can potentiallyaffect a surgical procedure for treating a urological disorder,including the efficacy and/or results. Features that can be differentaccording to the present invention include, but are not limited to theability of the sling to avoid infections or tissue erosion (actual orperceived), the shelf life of the material, the type of material, theshape of the material, the presence of a sling tensioning member (e.g.as disclosed in Published U.S. patent application Ser. No.2002/107430-A1), the present of a sling adjustment feature (as describedin U.S. patent application Ser. No. 10/004,185 filed Oct. 30, 2001),sling material treatment (e.g. heat set) or coating, the porosity of thesling material, the shape of the sling material, the strength of thematerial, the elastic property of the material, the potential for tissueingrowth, the biocompatibility of the material, and the presence orabsence of an insertion sheath. Examples of treatments or coatingsinclude anti-microbials, anti-biotics or other drug coatings.

[0075] Suitable non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia, autodermal grafts,dermal collagen grafts, autofascial heterografts, whole skin grafts,porcine dermal collagen, lyophilized aortic homografts, preserved duralhomografts, bovine pericardium and fascia lata. Suitable syntheticmaterials for a sling include polymerics, metals (e.g. silver filigree,tantalum gauze mesh, and stainless steel mesh) and plastics and anycombination of such materials.

[0076] Commercial examples of non-absorbable materials include Marlex™(polypropylene) available from Bard of Covington, R I, Prolene™(polypropylene), Prolene Soft Polypropylene Mesh or Gynemesh(nonabsorbable synthetic surgical mesh), both available from Ethicon, ofNew Jersey, and Mersilene (polyethylene terphthalate) Hernia Mesh alsoavailable from Ethicon, Gore-Tex™ (expanded polytetrafluoroethylene)available from W. L. Gore and Associates, Phoenix, Ariz., and thepolypropylene sling available in the SPARC™ sling system, available fromAmerican Medical Systems, Inc. of Minnetonka, Minn. Commercial examplesof absorbable materials include Dexon™ (polyglycolic acid) availablefrom Davis and Geck of Danbury, Conn., and Vicryl™ available fromEthicon. Other examples of suitable materials include those disclosed inpublished U.S. patent application Ser. No. 2002/0072694. More specificexamples of synthetic sling materials include, but are not limited topolypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene,polygalactin, Silastic, carbon-fiber, polyethylene, nylon, polyester(e.g. Dacron) polyanhydrides, polycaprolactone, polyglycolic acid,poly-L-lactic acid, poly-D-L-lactic acid and polyphosphate esters. SeeCervigni et al., The Use of Synthetics in the Treatment of Pelvic OrganProlapse, Current Opinion in Urology (2001), 11: 429-435.

[0077] The embodiment shown in FIGS. 1 and 2 includes an assembly tool20. Preferably, the implant 10 includes a Y-shaped portion includinglegs 16 and 18 and seam 15. A suitable assembly tool is disclosed inU.S. patent application Ser. No. 10/335,119, filed Dec. 31, 2002.Alternative approaches for forming the juncture between two dissimilarmaterials are also disclosed in that patent application. Preferably, theseam or juncture portion 15 is preferably spaced from the portion 12 ofthe implant 10 for supporting the urethra so that it does not liedirectly under the urethra. For example, the seam or junction 15 couldbe spaced between about 1 cm and about 5 cm from the edge, morepreferably between 2 cm and 4 cm, more preferably about 3 cm from theparallel edge. In an alternative embodiment, the seam or junction may beplaced on the major portion 32, 34 or 36 and the portion of the implantnear reference character 12 could be free of any seam or juncture.

[0078] As seen in FIG. 2, the tool 20 may be used to move first andsecond legs 16 and 18 of the implant 10 to an open position to affordinsertion of another component of the implant (e.g. 32, 34 or 36). Thetool has flanges 22 and 24 that are initially attached to the legs 16and 18 and are detachable from the legs as disclosed in the '119application. The tool 20 affords convenient suturing of one portion ofthe implant to another.

[0079]FIG. 27 shows another modular assembly 700 for affordingconstruction of a surgical implant for addressing one or more pelvicfloor disorders. The assembly comprises an anterior element 10 foraffording a sling-like implant. The anterior element 10 may be similarto the element 10 described with reference to FIG. 1, with likereference characters indicating like elements. Unlike the assembly ofFIG. 1, the assembly 700 of FIG. 27 also includes a posterior element704. The posterior element 704 includes distal end portions 717 and 719for securement in a posterior region of the patient's body. Optionalinsertion sheaths 711 and dilating connectors 754 may also be utilized.

[0080] The assembly 700 also includes a mid-portion or cystocele repairportion 32, 34 or 36 for affording repair of a cystocele. As depicted,the cystocele repair portion may be associated with either the anteriorelement or the posterior element or both elements. Preferably theassembly includes a means for facilitating association between elementsof the assembly such as tools 20. Alternatively the tools 20 may beplaced on the mid portion 32, 34 or 36 of the assembly 700 instead ofthe anterior and posterior portions. Also preferably, the cystocelerepair portion includes indicia to facilitate trimming to adjust theimplant to different sizes. A rectocele repair portion may also beprovided. In alternative embodiments, the rectocele repair portion maybe connected to the posterior portion 704 or the cystocele repairportion 32, 34 or 36.

[0081] Referring to FIG. 3, there is shown another embodiment of implant40 according to the present invention. The implant 40 includes first andsecond sling appendages 42 and 44 and a portion adapted to be secured inthe patient's vaginal region. The implant also has a first posteriorsecurement appendage 46 that is sized, shaped and configured to extendfrom the patient's vaginal region toward a first incision in thepatient's buttocks and lateral to the patient's anus; and a secondposterior securement appendage 48 that is sized, shaped and configuredto extend from the patient's vaginal region, on a side of the patient'sanus different than that of the first posterior securement appendage,toward a second incision in the patient's buttocks that is on a side ofthe patient's anus opposite the first incision. Preferably, the firstand second posterior securement appendages 46 and 48 have distal endregions adapted to be secured in the patient's ischioanal fossa oriscbiorectal fossa. Alternatively, instead of the linear edges shown inFIG. 3, the securement appendages may include curved edges to providearced or curved shaped appendages.

[0082] The implant 40 also preferably includes dilating connectors 54A.Suitable dilating connectors are disclosed in Published U.S. patentapplication Ser. Nos. 2002/151762 and 2002/147382 and U.S. patentapplication Ser. No. 10/386,897, filed Mar. 11, 2003.

[0083] In one embodiment, the portion of the synthetic implant 40designed to remain in vitro may comprise a mesh material. The meshmaterial comprises one or more woven, knitted or inter-linked filamentsor fibers that form multiple fiber junctions throughout the mesh. Thefiber junctions may be formed via weaving, molding, knitting, braiding,bonding, punching, ultrasonic welding or other junction formingtechniques, including combinations thereof. In addition, the size of theresultant openings or pores of the mesh may be sufficient to allowtissue in-growth and fixation within surrounding tissue.

[0084] A wide variety of factors affect an implant material'slongitudinal extensibility. The quantity and type of fiber junctions,yarn knit, fiber weave, pattern, and material type influence varioussling properties or characteristics. Other factors include heat set ofthe individual strands, the degree of tension at heat setting of themonofilaments, the diameter of the monofilament yarn, the bar settingson the knitting machine, coatings and finishes.

[0085] Referring to FIG. 4, there is shown another embodiment of implant80 according to the present invention. The implant comprises a syntheticmesh material that has a portion 82 adapted to be secured in the vaginalwall region via a vaginal incision. The synthetic mesh has incrementalindices 80A, 80B and 80C that can be used as a guide to trim to specificanatomical requirements for lateral and/or central defects. The implant80 has a first posterior securement appendage 86 that is sized, shapedand configured to extend from the patient's vaginal region toward afirst incision in the patient's buttocks and lateral to the patient'sanus; and a second posterior securement appendage 84 that is sized,shaped and configured to extend from the patient's vaginal region, on aside of the patient's anus different than that of the first posteriorsecurement appendage, toward a second incision in the patient's buttocksthat is on a side of the patient's anus opposite the first incision.Preferably, the first and second posterior securement appendages 86 and84 have distal end regions adapted to be secured in the patient'sischioanal fossa or ischiorectal fossa.

[0086] The implant 80 is preferably constructed from a longitudinallyextensible material. Optionally, the implant 80 utilizes insertionsheaths 87 for the first and second posterior securement appendages 86and 84. Also, the implant 80 preferably includes dilating connectors 54Badapted to associate the implant 80 with the distal end of an insertionneedle.

[0087] The implant 80 is particularly suitable for accommodating varyingdegrees of cystocele repairs for a central and lateral (white line)support. For example, the ends of the portion 82 may be sized and shapedto be sutured to the patient's arcus tendeneus (white line).Alternatively, if such support is not required, the ends of the portion82 could be secured to the sacrospinous ligaments, the levator anitissues, the utero-sacral ligamements.

[0088] In a preferred embodiment, the implant 80 is inserted through avaginal incision. The posterior appendages are used to secure the vaultby being pulled through the ischiorectal fossa while the mid portion issecured to the vaginal tissue. Optionally, the appendages may bepreattached to the cystocele patch portion or may be provided as aportion of a composite assembly, similar to assembly 10. Also, insteadof the straight appendages shown, another embodiment may comprise curvedappendages.

[0089] The indica or markings 80A, 80B and 80C are preferably spaced apredetermined distance from an edge of the implant 80. The indicia 80A,80B and 80C afford convenient, symmetrical trimming that can savesurgical time. Alternatively, instead of the curved shape, the indicia80A, 80B, 80C may comprise linear markings.

[0090] In another embodiment, the first sling appendage 86 may be sized,shaped and configured to extend from a region near the patient's urethrato the patient's obturator foramen, on a first side of the patient'surethra, and a second sling appendage 84 may be sized, shaped andconfigured to extend from a region near the patient's urethra to thepatient's other obturator foramen, on a side of the patient's urethragenerally opposite the first side.

[0091] Referring to FIG. 5, there is shown another embodiment of implant90 according to the present invention. The implant 90 comprises asynthetic mesh material that has a major portion 95 adapted to securedin the vaginal wall region (e.g. the vaginal apex or cuff), preferablyvia a vaginal incision. The synthetic mesh has incremental indices 90A,90B and 90C that can be used as a guide for trimming to specificanatomical requirements for lateral and/or central defects. The majorportion 95 also includes a urethral support portion capable of beingplaced underneath the patient's urethra.

[0092] The implant 90 includes a first sling appendage 94 for securementon a first side of the patient's urethra; and a second sling appendage92 for securement on a side of the patient's urethra generally oppositethe first side. The first sling appendage 94 is sized, shaped andconfigured to extend from a region near the patient's urethra to anincision in the patient's abdominal rectus fascia, on a first side ofthe patient's urethra, and the second sling appendage 92 is sized,shaped and configured to extend from a region near the patient's urethrato an incision in the patient's abdominal rectus fascia, on a side ofthe patient's urethra generally opposite the first side.

[0093] A hole 99 may be provided in the implant 90 to afford convenientconformation of the implant 90 to irregular anatomical structures.Optionally, the hole 90 may be situated to encompass the vaginalincision used to insert the implant 90 to avoid any contact between theimplant 90 and the incision.

[0094] In another embodiment, the first and second sling appendages aresized, shaped and configured to extend from a region near the patient'surethra to and/or through the patient's obturator foramen.

[0095] Referring to FIG. 6, in another aspect, the present inventioncomprises a surgical kit or assembly 100. The assembly 100 includesfirst and second insertion needles 116 and a longitudinally extendibleimplant capable of being secured in the posterior region of thepatient's body.

[0096] In another embodiment of surgical kit according to the presentinvention, third and fourth insertion needles (not shown in FIG. 6) mayalso be provided. These needles may be substantially similar to thefirst and second insertion needles or they may be different. Forexample, the third and fourth insertions needles may be designed for aspecific surgical approach (e.g. transobturator or suprapubic).

[0097] The first and second insertion needles 1 16 are configured sothat their distal ends 158 may be initially inserted through an incisionin the patient's buttocks and then passed through tissue, emergingthrough a vaginal incision. The first and second insertion needlespreferably have an outer diameter of less than about 4 mm, morepreferably less than about 3.3 mm to minimize tissue disruption anddamage.

[0098] The implant provided with the kit comprises a synthetic meshmaterial with a portion adapted to be secured in the patient's vaginalregion (preferably by virtue of a suture that does not go through thevaginal mucosa), a first posterior securement appendage that is sized,shaped and configured to extend from the patient's vaginal region towarda first incision in the patient's buttocks and lateral to the patient'sanus; and a second posterior securement appendage that is sized, shapedand configured to extend from the patient's vaginal region, on a side ofthe patient's anus different than that of the first posterior securementappendage, toward a second incision in the patient's buttocks that is ona side of the patient's anus opposite the first incision.

[0099] Preferably, the portion of the implant adapted to be secured inthe patient's vaginal region is adapted to be sutured to the patient'svaginal apex. The implant 40 of FIG. 6 is a relatively complex shape,but alternatively, referring to FIG. 25 the implant can comprise asubstantially rectangular, longitudinally extendible implant material944 with first and second flexible insertion sheaths. The kit of FIG. 25preferably includes dilating connectors 954 and at least two, relativelysmall (i.e. outer diameter less than about 4 mm) needles 960.

[0100] While the implant 40 depicted in FIG. 6 is preferably constructedfrom a longitudinally extendable material, it is within the scope of thepresent invention to provide a kit comprising an inextensible implantand at least two posterior implantation needles.

[0101] A surgical kit 100 according to the present invention mayoptionally include additional accessories. For example, a surgical drapespecifically designed for urological procedures such as a slingprocedure may be included in a kit of the present invention. Such adrape is disclosed in published U.S. patent application Ser. No.2002-078964-A1. Alternatively, an article for objectively settingtension of the sling, such as one of the articles described in U.S.patent application Ser. No. 09/968,239, filed Oct. 1, 2001 may beincluded in the kit.

[0102] The kits 100 preferably include at least two needles. In variousembodiments of the present invention, the needles may comprise theneedles described in published U.S. patent application Ser. Nos.20023-0065246-A1; 2002-0151762-A1; 2002-0147382-A1; 2002-0107430-A1,U.S. patent application Ser. No. 2002-0099258-A1 and U.S. patentapplication Ser. No. 2002-0099259-A1; and U.S. Provisional ApplicationSerial Nos. 60/263,472, filed Jan. 23, 2001; 60/269,829, filed Feb. 20,2001; 60/281,350, filed Apr. 4, 2001; 60/295,068, filed Jun. 1, 2001;60/306,915, filed Jul. 20, 2001, and 60/332,330, filed Nov. 20, 2001. Inan embodiment that is particularly suitable for a transobturatorsurgical procedure, the needles comprise needles as described in U.S.patent application Ser. No. 10/306,179 filed Nov. 27, 2002.

[0103] The outer diameter of the optional dilators is also preferablysmall and may comprise the dilators disclosed in U.S. patent applicationSer. No. 10/386,897 filed Mar. 11, 2003.

[0104] In some instances the needles may be substantially identical, inother instances, they may be different. Two or more needles reduce theneed to reuse a non-sterile needle at a different location with apatient, thereby eliminating cross contamination issues. Additionalneedles, handles, dilators and other elements may also be included forsurgical convenience, for avoidance of contamination from one portion ofthe body to another, for ease of manufacturing or sterilization or forsurgical requirements.

[0105] The individual elements of the kits of the present invention maybe packaged together as shown in FIG. 6 with a cover C and tray T.Alternatively, the individual elements may be separately packaged orpackaged in subassemblies depending on a variety of factors such asshelf life and sterilization requirements. They may be assembled at themanufacturing location or at the healthcare location. Any suitablesterilization procedure may be utilized to sterilize the contents of akit. Suitable sterilization techniques include, but are not limited tosteam, ethylene oxide, electron beam, vapor (e.g. hydrogen peroxide orperacetic acid), gamma or plasma procedures.

[0106] The above-described insertion needles may be disposable orreusable. They may be malleable (manually bendable) or rigid.Optionally, portions of the insertion needles may be reusable(sterilizable) and other components may be disposable.

[0107]FIG. 26 shows another embodiment of implant assembly 800 accordingto the present invention. The implant assembly 800 comprises a syntheticmesh having a major portion 842P, and at least four projectionsextending from the major portion 842P. The implant assembly 800 may beused as a hammock to support the bladder or for other procedures toaddress a cystocele or prolapse or a vaginal vault treatment. Each ofthe projections preferably has a dilating connector 854P associated witha distal end. The projections may be implanted via transobturator,suprapubic or posterior techniques. For example, one of the projectionsmay be placed on a first side of the patient's urethra and extend fromthe patient's urethral region to the patient abdominal rectus fascia,and another of the projections is adapted to be placed on a side of thepatient's urethra generally opposite the first side.

[0108] As another example, one of the projections may be anchored in thepatient's right obturator foramen, another of the projections may beanchored in the patient's left obturator foramen and the other twoprojections may extend to the patient's rectus abdominus fascia. Variousanchoring techniques may be utilized including those disclosed inpublished U.S. patent application Ser. No. 2002/0161382-A1. In thisembodiment, the central portion of the implant 800 may be secured in thevaginal region for vaginal vault or cystocele repairs.

[0109] In yet another embodiment, two of the projections may be anchoredin the patient's left obturator foramen and the other two projectionsmay be anchored in the patient's right obturator foramen. The centralportion may be secured in the vaginal region to address pelvicdisorders.

[0110] Referring now to FIG. 14, there is shown another embodiment ofimplant 200 according to the present invention. The implant 200 includesa synthetic mesh material having a portion 204 adapted to be secured inthe patient's vaginal region, a first posterior securement appendage 212that is sized, shaped and configured to extend from the patient'svaginal region toward a first incision in the patient's buttocks andlateral to the patient's anus; and a second posterior securementappendage 214 that is sized, shaped and configured to extend from thepatient's vaginal region, on a side of the patient's anus different thanthat of the first posterior securement appendage, toward a secondincision in the patient's buttocks that is on a side of the patient'sanus opposite the first incision. Optionally, the implant 200 mayinclude a first flexible insertion sheath 211 associated with at least aportion of the first posterior securement appendage, and a secondflexible insertion sheath 211 associated with at least a portion of thesecond posterior securement appendage 214.

[0111] The implant 200 also includes a first sling appendage 216 forsecurement on a first side of the patient's urethra; and a second slingappendage 218 for securement on a side of the patient's urethragenerally opposite the first side of the urethra. Optional insertionsheaths 211 may also be utilized.

[0112] The implant 200 may also include dilators 254 (e.g. as disclosedin published U.S. patent application Ser. No. 2002/151762-A1).Preferably, the dilators 254 include a connector for connecting to thedistal end of a surgical needle.

[0113] In a preferred embodiment, the first and second posteriorsecurement appendages 212 and 214 have distal end regions adapted to besecured in the patient's ischioanal fossa or ischiorectal fossa.Alternatively, the first and second posterior securement appendages havedistal end regions adapted to be secured in the patient's sacrospinousligaments, the uterosacral ligaments, or the levator ani muscles.Preferably, the connectors include surfaces for dilating tissue.

[0114] The implant 200 also preferably includes a slit or slot 221. Theslit 221 may help the implant 200 conform to irregular surfaces such asthe vaginal apex or cuff. Alternatively, the slit may be designed toform a hole when the implant conforms to an irregular surface. In apreferred embodiment, that hole can be situated to encompass the vaginalincision used to insert the implant 200 to avoid post implantationcontact between the implant 200 and the surgical incision.

[0115] The portion 204 is preferably sized and shaped to affordcystocele repairs. The maximum width of the central portion 204 ispreferably between about 2 and 20 cm, and the length is also betweenabout 2 and 20 cm. Markings may be provided to afford trimming in asymmetrical fashion or to provide strategic slits for conforming theimplant to an irregular surface. A 6 inch×6 inch or 15 cm×15 cm centralportion are within the scope of an aspect of the present invention. Theappendages 212, 214, 216 and 218 may have the widths and lengths similarto the width and length ranges described with reference to previousembodiments. As an example, the length between distal ends of theappendages 212 and 214 as measured along their longitudinal axis andacross a portion of central portion 204 is preferably between about 40and 55 cm. The width is preferably between 0.5 and 1.5 cm. The lengthbetween distal ends of the appendages 216 and 218 as measured alongtheir longitudinal axis and across a portion of central portion 204 maybe slightly less than that of the appendages 212 and 214. For example,the length may be between about 25 cm and 50 cm, more preferably about38 cm in length. The width may also be less, preferably between about0.4 cm and about 1.2 cm.

[0116] In another embodiment of the invention of FIG. 14, the appendages214 and 218 may be sized and shaped to extend to and/or through thepatient's left obturator foramen, and the appendages 212 and 216 may besized and shaped to extend to and/or through the patient's leftobturator foramen. In this embodiment, both appendages 214 and 218 maybe attached to a single dilator instead of two separate dilators in FIG.14. Correspondingly, both appendages 212 and 216 may likewise beattached to a single dilator.

[0117] The appendages may project from the longitudinal axis of themajor portion 204 at an angle between 0 and 90 degrees. Additionally,instead of the substantially rectangular, straight appendages, theappendages may be curved.

[0118] The implant 200 may be substantially symmetrical about itslongitudinal axis. In some embodiment, the implant 200 may beasymmetrical about an axis transverse to the longitudinal axis. Theimplant may include indicia 208 indicating an appropriate position fortrimming. If the implant is not symmetrical or would require aparticular orientation (e.g. for the slit 221 to encompass the vaginalapex), the indicia 208 may include text or other symbols indicating theproper orientation (e.g. posterior or anterior).

[0119]FIG. 15 shows a unitary, modular implant 300. The implant 300includes projections 312, 314, 316, 318 and a major portion with indicia303, 305, 307. The indicia and size and shape of the implant 300 allowthe surgeon to conveniently choose a portion of the graft for singleand/or multiple repairs. For example, a bladder tape sling procedure canbe accomplished either through a transobturator needle approach orsuprapubic needle approach. The central portion can be trimmed to repaira central or lateral anterior vaginal wall repair. The demarcations 303,305 and 307 can be utilized to help symmetrically trim either side toattach or lay a portion of the implant along the white line or arcustendinae. The indicia may also be used to indicate strategic positionsfor slits to be placed to help the implant conform to an irregularsurface. While the indicia 303, 305 and 307 are shown as arcuate lines,other shapes, such as straight lines, are also within the scope of thepresent invention.

[0120] The posterior appendages 312 and 314 can be used to restoreapical support by attaching the vaginal cuff to the mesh and pulling theappendages through rectal fascia to pull the apex back via theischiorectal fossa needle passage or via the transobturator needlepassage. The graft materials for the appendages or portions thereof mayor may not be the same material as the central-portion depending on thepreferred mesh properties for each repair. The middle portion of thegraft 300 is preferably an open mesh knit to afford a supple andcompliant graft in the anterior vaginal wall that allows tissueingrowth. The appendages also preferably afford tissue ingrowth toafford anchoring in the fascia for bladder and vault support. The graftmaterial 300 preferably has some demarcations 335 at the appendage sitesas well as along the mid portion of the graft that can be used toidentify where the surgeon can cut depending on what type of repair isto be conducted.

[0121] The implant 300 depicted in FIG. 15 does not include insertionsheath to point out that some complex shaped implants of the presentinvention could be constructed from a material that does not readilyelongate under longitudinal forces. While not preferred, such an implantmay be implanted by the use of preattached sutures 321 (describedbelow).

[0122] The present invention contemplates a variety of different sizesand shapes for the central portion of the implant 300. As an example,not intended to be limiting, the central portion may comprise a 6 inch×6inch mesh. Other sizes are also contemplated (e.g. a 12 cm×12 cm centralportion, as the distance from one ischial spine to another is oftenabout 9-10 cm). Alternatively, instead of a square or rectangular shapedcentral portion, the edges may be curved.

[0123] The implant 300 may be constructed from a longitudinallyextendable or longitudinally non-extendable material. Optionally,sutures 321 may be preattached to the appendages 312, 314, 316 and 318.The sutures 321 may be used to secure the implant 300 in the pelvicregion. Alternatively, the sutures may connect an appendage to aninsertion needle (e.g. with an eyelet or fish-hook shaped slot) toafford insertion of the implant. If a longitudinally extendable materialis used, insertion sheaths may be provided for the appendages 312, 314,316 and 318.

[0124] Optional dilators 354 are shown. The dilators include holes 351.Sutures 321 may be tied in holes 351 to afford association with thedilators 354. Notably, the sutures 321 for appendages 314 and 316 couldbe tied in the hole 351 of a single dilator 354 and then passed to thepatient's obturator foramen. Other associations between an implantmaterial, sutures, sheaths and dilator are contemplated herein includingthose shown in published U.S. patent application Ser. No. 2002/147382-A1and U.S. patent application Ser. No. 10/386,897, filed Mar. 11, 2003.

[0125] Referring to FIG. 16, there is shown an implant substantiallyidentical to that of FIG. 15, with like reference characters in FIG. 16being substantially the same as the elements of the implant shown inFIG. 15. Unlike FIG. 15, the implant shown in FIG. 16 a portion 330 thatis sized and shaped to afford a concomitant rectocele repair. Theportion 330 may, for example have a length of about 6 cm.

[0126] Another embodiment of implant 440 is shown in FIGS. 17 and 18.The implant includes first and second sling portions 442 and 444.Preferably, the implant 440 includes insertion sheaths 441 and dilatingconnectors 454, but these may be omitted (e.g. if the implant isconstructed form a suitable material). The implant 440 includes a midportion 443 and flap 458 secured to the mid portion 443 along junction445.

[0127] The implant 440 also includes first and second posteriorsecurement appendages 446 and 448, preferably sized and shaped to beplaced in the patient's ischioanal fossa or ischiorectal fossa. Optionalinsertion sheaths 447 and dilating connectors 454A may be provided.

[0128]FIG. 19 schematically illustrates the implant 443 afterimplantation. The sling appendages 442 and 444 are preferably placedmid-urethra in a tension free manner. Alternatively, the slingappendages 442 and 444 may be placed at the bladder neck. The posteriorsecurement appendage 446 (not shown in FIG. 19) and 448 are placed inthe patient's buttocks region (e.g. ischia fossa) on opposite sides ofthe patient's anus A. The view is slightly distorted to illustratecertain details. For example, the posterior securement appendage 448preferably exits at or about the level of the anus A, not above it asshown. The flap 458 and mid portion 443 are placed about the vaginalapex and can be secured by suturing to the vaginal tissue.

[0129]FIG. 20 shows another embodiment of implant 500 according to thepresent invention. The implant includes sling appendages 542 and 544 andoptional insertion sheaths 541 and dilator connectors 554. Unlikeimplants with posterior securement appendages designed for implantationin the patient's buttocks, the implant 500 includes a portion having anend 501 that may be secured to the patient's sacrum (e.g. via boneanchors with associated sutures as shown in Published U.S. patentapplication Ser. No. 2002/0028980) so that a combination sacralcolpopexy and sling procedure can be accomplished with a single implant500. Optionally, the implant 500 includes a flap similar to the flap 458shown in FIGS. 17-18. The length of the implant between end 501 and anopposite end may be between about 6 and 12 inches, more preferablybetween 8 and 12 inches. The width of end 501 is preferably between 0.75and 2 inches wide. The optional flap may be situated between about 4 and6 inches from the end 501.

[0130]FIGS. 23 and 24 show another embodiment of implant 600 accordingto the present invention. The implant includes sling appendages 642 and644 and optional dilators 654. The appendages may be curved orsubstantially rectangular (as shown) and may project from a majorportion 643 of the material at an angle between 0 and 90 degrees. Theimplant 600 also has posterior securement appendages 646 and 648.

[0131] The implant 600 has indicia 651 and 653 that allow the implant tobe used in a universal manner. The implant may be trimmed along theindicia 651 to address different sizes of cystocele, or rectocele anddifferent anatomy sizes. In addition to a trimming pattern, the indiciacan include measurement marking (e.g. cm distances) to assist thesurgeon in trimming the implant to its desired size and shape. Forexample, for a small anatomy or a small cystocele, the surgeon may trimalong lines 651 and cut out a portion of the central part 643 of theimplant. The surgeon need not trim along transverse indicia 653.Instead, the surgeon may trim along lines 651 and use the portion of theimplant between the trims for a rectocele repair.

[0132] The implant preferably includes insertion sheaths 647 and 641.Referring to FIG. 24, the sheaths 647 preferably comprise an extendablemember that can be movable from i) a retracted position with a portionof the sheath Z-folded as shown in FIG. 24, to ii) an extended positionwith additional of the material of the implant covered by the sheath.This is particularly useful when the portion of the implant alongindicia 651 and 653 is removed. It is believed that extending the sheathover additional parts of the implant may afford a more convenientinsertion of this portion of the implant. An extendable sheath may beaccomplished in a variety of fashions including Z-folding the sheath,constructing the sheath of a stretchable or expandable material, and thelike.

[0133] Examples of Materials

[0134] In one aspect, the present invention comprises a longitudinallyextendable synthetic material in an implant secured in a posteriorregion of the body. For example, the implant of FIG. 25 is a rectangularimplant that may be sutured or otherwise associated with the vaginalregion (e.g. the vaginal apex) to address vaginal vault prolapse or tosupport the vault. Preferably, distal end regions 942 of the implant aresecured in the ischioanal fossa or ischiorectal fossa of the patient'sbuttocks. The length of this embodiment is preferably between 25 and 45cm, more preferably between 30 and 40 cm. The width is preferablybetween 0.5 cm and 1.5 cm, more preferably about 1 cm. The bulksynthetic may be knitted, woven, sprayed or punched from a blank.

[0135] Preferably, longitudinally extendible implants have an associatedremovable insertion sheath or sleeve (e.g. 47 in FIG. 3 or 944 in FIG.25). The sheath is preferably made of polyethylene and is substantiallytransparent or translucent. Other materials include without limitation,polypropylene, nylon, polyester or PTFE (polytetrafluoroethylene,Teflon). The sheath material should be flexible and provide sufficientstructural integrity to withstand the various forces exerted on thesheath throughout the implant delivery procedure. The sheath should alsoconveniently separate from a knitted implant material after the implantis implanted without materially changing the position of the implant invitro.

[0136] As Sample A (see below), a mesh included polypropylenemonofilaments, knitted with a warp tricot. The stitch count was 27.5courses/inch (+ or −2 courses) and 13 wales/inch (+ or −2 wales). Thethickness of this example is 0.024 inches. The average flexural rigiditywas about 257.8 (g-cm). The fiber size was about 0.0046 inches. Theaverage mesh density (in g/cm3) was about 0.125. In Sample A, the holescomprised polygonal shaped holes with diagonals of 0.132 inches and0.076 inches. A sample of this bulk material is available in the SPARCSling System, commercially available from American Medical Systems ofMinnetonka, Minn.

[0137] A test may be conducted on a 0.8 mm by 3 inch sample of a bulkmaterial to determine its Longitudinal Extensibility Factor (LEF) underdifferent loads. The test may utilize a series IX Automated MaterialsTesting System (an Instron), available from Instron Corporation. An 8 mmwide sample of the mesh may be placed in the Instron with a crossheadspeed set at 5 in/min. The 3 inch test sample is inserted to provide agauge length of 1 inch. Referring to FIG. 21, the length X is 1 inch.

[0138] Referring to FIG. 21, the bulk mesh material may be subjected tovarious loads F. The amount that the sample increases in length X′ underthe load F is shown in FIG. 22.

[0139] The above identified test was conducted on three separatesamples. The first sample (Prior Art) was an 8 mm×3 inch prior artsample obtained from the material provided with the IVS Tunnelerproduct. Sample A was an ethylene oxide sterilized mesh as describedabove. Sample B comprised a 0.8 mm×3 inch sample of a Prolene Mesh,which is a knitted polypropylene monofilament mesh, commerciallyavailable from Ethicon of New Jersey. Sample B was tested bothlongitudinally and a direction perpendicular to the longitudinaldirection. Longitudinal Elongation Factor Elongation (in/in of length) @various loads (lbf) Load at Disp. Max At Max. Load Sample # 0.5 lbf 1.0lbf 1.5 lbf 2.0 lbf Load (lbf) Prior Art A 0.05 0.07 0.090 0.11 0.43410.58 B 0.17 0.23 0.28 0.33 1.267 12.96 longitudinally 0.35 0.53 0.610.74 1.2 6.86 B Perpendicular 0.082 0.17 0.28 0.37 0.80 12.43 to Long.Axis

[0140] A longitudinally extensible mesh exhibits at least a LongitudinalElongation Factor (LEF) of 0.06 under a ½ pound load, more preferably aLEF of more than about 0.08 under a ½ pound load, and more preferably aLEF of more than about 0.15 under a ½ pound load. A longitudinallyextensible mesh exhibits a LEF of at least 0.08 under a 1 pound load,more preferably a LEF of more than about 0.1 under a 1 pound load, andmore preferably an LEF of more than about 0.2 under a 1 pound load.Additional results may be seen in the table.

[0141] In contrast, the longitudinally inextensible mesh associated withthe IVS Tunneller device exhibited an LEF of less than 0.05 under a ½pound load, and less than 0.07 under a 1 pound load.

[0142] Bulk mesh materials used to create Samples A and B may be cutinto any of a wide variety of shapes, including those shown in thefigures of this application and others. For example, a simplerectangular shape may be utilized with dimensions of about 1 inch×about6 inches. In this example, the mid region of the rectangle could besutured to the vagina (e.g. in the vaginal apex region) and the ends ofthe longitudinally extendible material may be secured in the patient'sischioanal fossa or ischiorectal fossa.

[0143] Examples of Surgical Procedures

[0144] Several methods are contemplated herein. Although the methods ofuse as disclosed herein generally relate to female prolapse conditionsand treatments/procedures, incontinence conditions andtreatments/procedures are also included within the scope of the presentinvention.

[0145] A variety of different surgical approaches are contemplatedherein including a supra-pubic (i.e. the distal end of a needleinitially being inserted through an abdominal incision and then emergingfrom a vaginal incision), trans vaginal (the distal end of an insertionneedle being initially inserted through a vaginal incision and thenemerging from an abdominal incision), trans-obturator (e.g. the distalend of a needle initially being inserted through an incision in skinnear the patient's obturator foramen and then emerging from a vaginalincision or vice versa) and posterior approaches. Preferably, theimplants according to the present invention are inserted through avaginal incision. Alternative insertion routes such as laparoscopic andthrough an open abdominal incision are also within the scope of thepresent invention.

[0146] It should be noted that the present invention is particularlysuitable for placing an implant in a therapeutically effective position.The method may be utilized to support a variety of structures atdifferent anatomical locations. Variations of these methods may occurdue to individual surgeon's techniques or a patient's particularanatomy. For example, the amount of dissection employed varies greatlybetween surgeons and procedures. As another example, the particularorder in which the elements of the implant are secured are also withinthe individual surgeon's discretion. Some surgeons may initially place acystocele repair portion of an implant and then secure sling appendages.Others may initially place sling appendages and then secure a cystoceleportion of the implant. As yet another example, some surgeons may electto secure an implant to the vaginal cuff or apex, other surgeons mayelect to place sutures through the implant and a portion of theposterior or anterior wall of the vagina.

[0147] As another example, there are a variety of different methods ofattaching an implant in the vaginal region for purposes of vaginal vaultsupport or correction of vaginal vault prolapse. Some surgeons maysuture a mid region of a rectangular mesh to the vaginal region (e.g.apex). This is preferably conducted without traversing through vaginalmucosa.

[0148] In embodiments of the present invention that include slingappendages, the sling appendages are preferably implanted mid-urethra ina tension free manner. Preferably the implant is slightly spaced fromthe urethra. Also preferably, in embodiments of implants that include acystocele repair portion, the implant is secured in a tension freemanner without traction on the bladder.

[0149]FIG. 7 schematically illustrates a patient's anatomy including thebladder B, urethra U, vagina V and anus A. The bladder B is shownslightly prolapsed into the vagina V. Often such patents exhibit stressurinary incontinence.

[0150] Referring to FIGS. 8 through 13 schematically illustrate aprocedure for addressing vaginal prolapse through a posterior surgicalapproach. Referring to FIG. 8, in contrast to some prior art surgicalprocedures, a kit according to the present invention utilizes two,independent sterile needles 116. Preferably, the needles 116 utilizehandles 112 and have distal ends 158.

[0151] Incisions I′ are placed laterally on each side of the anus A.Preferably, the incisions are placed proximate the patient's ischioanalfossa or ischiorectal fossa. Referring to FIG. 9, a needle 116 is passedinitially through the incision I′ and is guided to meet the surgeon'sfinger F. FIG. 11 shows the distal end 158 of the needle 116 meeting thesurgeon's finger F exposed by retractors 103.

[0152]FIG. 10 shows the distal end 158 of the needle 116 after itemerges from an incision I in the vaginal region (e.g. in the region ofthe vaginal apex or cuff). A dilator 58 (in this case associated withthe implant and an insertion sheath) is then attached to the distal endof the needle. In this case, the implant may simply be a rectangular,longitudinally extendible implant and insertion sheath. To correct avaginal prolapse with such an implant, the mid portion may be sutured tothe vagina (e.g. in the vaginal cuff region) via the incision I. Thenthe distal ends of the implant may be connected to the distal ends 158of the needles 116 and moved from the vaginal region through theischioanal fossa or ischiorectal fossa IF and appropriately tensioned.FIG. 12 shows the distal ends of the mesh projecting through incisionsin the buttocks. The insertion sheaths are then removed from theimplant. Optional tensioning sutures in the mesh may optimally beprovided to fine tune the final placement of the mesh. Tensioningsutures may also afford adjustment of implant position in the immediatepost operative period. Preferably, the vagina is secured in a tensionfree manner.

[0153]FIG. 13 illustrates placement of a more complex mesh shapeaccording to the present invention. In this embodiment, two appendagesof the implant 300 are passed suprapubically to provide sling likesupport to the urethra to address incontinence, and two other appendagesare passed posteriorly through ischioanal fossa or ischiorectal fossa tosecure the implant 300. Notably, the implant 300 simultaneouslyaddresses incontinence and prolapse.

[0154] All patents, patent applications, and publications cited hereinare hereby incorporated by reference in their entirety as ifindividually incorporated.

[0155] Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A surgical implant for addressing a femalepatient's pelvic health disorder comprising: a mesh having a majorportion that is sized and shaped to afford repair of a cystocele withoutlifting the patient's bladder and without placing tension on thebladder, the major portion including a urethral support portion capableof being placed underneath the patient's urethra; a first slingappendage for securement on a first side of the patient's urethra; and asecond sling appendage for securement on a side of the patient's urethragenerally opposite the first side.
 2. A surgical implant according toclaim 1 wherein the first sling appendage is sized, shaped andconfigured to extend from a region near the patient's urethra to thepatient's abdominal rectus fascia, on a first side of the patient'surethra, and the second sling appendage is sized, shaped and configuredto extend from a region near the patient's urethra to the patient'sabdominal rectus fascia, on a side of the patient's urethra generallyopposite the first side.
 3. A surgical implant according to claim 1wherein the first sling appendage is sized, shaped and configured toextend from a region near the patient's urethra to the patient'sobturator foramen, on a first side of the patient's urethra, and thesecond sling appendage is sized, shaped and configured to extend from aregion near the patient's urethra to the patient's other obturatorforamen, on a side of the patient's urethra generally opposite the firstside.
 4. A surgical implant according to claim 1 wherein the meshmaterial comprises bulk knitted polypropylene monofilaments, and bulkmaterial from which the mesh is supplied has at least a LongitudinalElongation Factor (LEF) of 0.06 under a ½ pound load.
 5. A surgicalimplant according to claim 1 wherein the implant is a compositeconstructed of two different implantable materials.
 6. A surgicalimplant according to claim 1 wherein the major portion has a lengthsufficient to afford anchoring in the region of the patient's sacrum. 7.A surgical implant for addressing a female patient's pelvic healthdisorder comprising: a synthetic mesh material having a portion adaptedto be secured in the patient's vaginal region, a first posteriorsecurement appendage that is sized, shaped and configured to extend fromthe patient's vaginal region to a first incision in the patient'sbuttocks that is lateral to the patient's anus; a second posteriorsecurement appendage that is sized, shaped and configured to extend fromthe patient's vaginal region, on a side of the patient's anus differentthan that of the first posterior securement appendage, to a secondincision in the patient's buttocks that is on a side of the patient'sanus opposite the first incision; and bulk material from which the meshis supplied has at least a Longitudinal Elongation Factor (LEF) of atleast 0.06 under a ½ pound load.
 8. A surgical implant according toclaim 7 wherein the first and second posterior securement appendageshave distal end regions adapted to be secured in the patientsischiorectal fossa.
 9. A surgical implant according to claim 7 whereinthe portion adapted to be secured in the patient's vaginal region issized and shaped to afford repair of a cystocele.
 10. A surgical implantaccording to claim 7 further including a portion that is sized andshaped to afford repair of a rectocele.
 11. A surgical implant accordingto claim 7 wherein bulk material from which the mesh is supplied has atleast a Longitudinal Elongation Factor (LEF) of more than about 0.08under a ½ pound load.
 12. A surgical implant according to claim 11wherein bulk material from which the mesh is supplied has at least aLongitudinal Elongation Factor (LEF) of more than about 0.15 under a ½pound load.
 13. A surgical implant according to claim 7 wherein bulkmaterial from which the mesh is supplied has a Longitudinal ElongationFactor (LEF) of more than about 0.08 under a 1 pound load.
 14. Asurgical implant according to claim 13 wherein bulk material from whichthe mesh is supplied has a Longitudinal Elongation Factor (LEF) of morethan about 0.1 under a 1 pound load.
 15. A surgical implant according toclaim 14 wherein bulk material from which the mesh is supplied has aLongitudinal Elongation Factor (LEF) of more than about 0.2 under a 1pound load.
 16. A surgical implant for addressing a female patient'spelvic health disorder comprising: a synthetic mesh material having aportion adapted to be secured in the patient's vaginal region, a firstposterior securement appendage that is sized, shaped and configured toextend from the patient's vaginal region toward a first incision in thepatient's buttocks that is lateral to the patient's anus; a secondposterior securement appendage that is sized, shaped and configured toextend from the patient's vaginal region, on a side of the patient'sanus different than that of the first posterior securement appendage,toward a second incision in the patient's buttocks that is on a side ofthe patient's anus opposite the first incision, a first flexibleinsertion sheath associated with at least a portion of the firstposterior securement appendage, and a second flexible insertion sheathassociated with at least a portion of the second posterior securementappendage.
 17. A surgical implant according to claim 16 wherein thefirst and second posterior securement appendages have distal end regionsadapted to be secured in the patient's ischioanal fossa.
 18. A surgicalimplant according to claim 16 wherein the first and second posteriorsecurement appendages have distal end regions adapted to be secured inthe patient's sacrospinous ligaments.
 19. A surgical implant accordingto claim 16 wherein the first and second posterior securement appendageshave distal end regions adapted to be secured in the patient'suterosacral ligaments.
 20. A surgical implant according to claim 16wherein the first and second posterior securement appendages have distalend regions adapted to be secured in the patient's levator ani tissue.21. A surgical implant according to claim 16 further including a firstdilator associated with the first posterior securement appendage, and asecond dilator associated with the second posterior securementappendage.
 22. A surgical implant according to claim 16 furtherincluding a first connector capable of associating the first securementappendage with a needle, and a second connector capable of associatingthe second securement appendage with a needle.
 23. A surgical implantfor addressing incontinence and cystocele disorders comprising: asynthetic mesh material having a cystocele repair portion adapted to besecured in the patient's vaginal region, a first posterior securementappendage that is sized, shaped and configured to extend from thepatient's vaginal region toward a first incision in the patient'sbuttocks that is lateral to the patient's anus; a second posteriorsecurement appendage that is sized, shaped and configured to extend fromthe patient's vaginal region, on a side of the patient's anus differentthan that of the first posterior securement appendage, toward a secondincision in the patient's buttocks that is on a side of the patient'sanus opposite the first incision, the implant including a urethralsupport portion capable of being placed underneath the patient'surethra; a first sling appendage for securement on a first side of thepatient's urethra; and a second sling appendage for securement on a sideof the patient's urethra generally opposite the first side of theurethra.
 24. A surgical assembly for addressing a female patient'spelvic health disorder comprising: a synthetic mesh material having aportion adapted to be secured in the patient's vaginal region, a firstposterior securement appendage that is sized, shaped and configured toextend from the patient's vaginal region toward a first incision in thepatient's buttocks that is lateral to the patient's anus; a secondposterior securement appendage that is sized, shaped and configured toextend from the patient's vaginal region, on a side of the patient'sanus different than that of the first posterior securement appendage,toward a second incision in the patient's buttocks that is on a side ofthe patient's anus opposite the first incision, the first and secondposterior securement appendages including a connector for associatingthe first and second posterior securement appendages with a distal endof an insertion needle.
 25. An assembly according to claim 24 whereinthe connectors include surfaces for dilating tissue.
 26. An assembly foraddressing a female patient's pelvic health disorder comprising: a firstinsertion needle having a distal end; a second insertion needle having adistal end; the first and second insertion needles being configured sothat the distal end may be initially inserted through an incision in thepatient's buttocks and then passed through tissue, emerging through avaginal incision; and an implant comprising a synthetic mesh materialhaving a portion adapted to be secured in the patient's vaginal region,a first posterior securement appendage that is sized, shaped andconfigured to extend from the patient's vaginal region toward a firstincision in the patient's buttocks that is lateral to the patient'sanus; a second posterior securement appendage that is sized, shaped andconfigured to extend from the patient's vaginal region, on a side of thepatient's anus different than that of the first posterior securementappendage, toward a second incision in the patient's buttocks that is ona side of the patient's anus opposite the first incision, a firstflexible insertion sheath associated with at least a portion of thefirst posterior securement appendage, and a second flexible insertionsheath associated with at least a portion of the second posteriorsecurement appendage.
 27. An assembly according to claim 26 wherein theportion of the implant adapted to be secured in the patient's vaginalregion is adapted to be sutured to the patient's vaginal apex.
 28. Anassembly according to claim 26 further including first and seconddilating connectors attached to the first and second flexible insertionsheaths for affording association between the implant and the distalends of the first and second insertion needles.
 29. A surgical implantfor addressing a female patient's pelvic floor disorder comprising: asynthetic mesh having a major portion, and at least four projectionsextending from the major portion, one of said projections adapted to beplaced on a first side of the patient's urethra and extend from thepatient's urethral region to the patient abdominal rectus fascia, andanother of said projections adapted to be placed on a side of thepatient's urethra generally opposite the first side.
 30. A surgicalimplant according to claim 29 wherein the synthetic mesh comprises aknitted polypropylene.
 31. An implant according to claim 29 furtherincluding a connector for associating the implant with an insertionneedle.
 32. An implant according to claim 29 including four connectorsfor associating the implant with four insertion needles.
 33. An implantaccording to claim 29 wherein the implant affords cystocele repair. 34.An implant according to claim 29 wherein the implant affords vaginalvault prolapse repair.
 35. An implant according to claim 29 wherein theprojections are associated with insertion sheaths for aiding inimplantation of the implant.
 36. An implant according to claim 29wherein the implant affords enterocele repair.
 37. A modular assemblyfor affording construction of a surgical implant for addressing one ormore pelvic floor disorders comprising: an anterior element foraffording a sling-like implant; a posterior element for securement in aposterior region of the patient's body; and a cystocele repair portionfor affording repair of a cystocele, wherein the cystocele repairportion may be associated with either the anterior element or theposterior element or both elements.
 38. An assembly according to claim37 further including a means for facilitating association betweenelements of the assembly.
 39. An assembly according to claim 37 whereinthe cystocele repair portion includes indicia to facilitate trimming toadjust the implant to different sizes.